Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
NCT ID: NCT04197440
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-01-15
2020-12-15
Brief Summary
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Detailed Description
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The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
SINGLE
Study Groups
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Bam8-22
BAM8-22 2mg/ml
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 1mg/ml
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 0.5 mg/ml
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Placebo
20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
SPT pricks
BAM8-22 with 1 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
BAM8-22 with 5 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
BAM8-22 with 25 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
BAM8-22 with inactivate cowhage spicules
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
Interventions
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BAM8-22 2mg/ml
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 1mg/ml
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 0.5 mg/ml
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Placebo
20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 with 1 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
BAM8-22 with 5 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
BAM8-22 with 25 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
BAM8-22 with inactivate cowhage spicules
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
Eligibility Criteria
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Inclusion Criteria
* 18-60 years
* Speak and understand English
Exclusion Criteria
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Moles, wounds, scars or tattoos in the area to be treated or tested
* Lack of ability to cooperate •
* Current use of medications that may affect the trial such as antihistamines and pain killers.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
18 Years
60 Years
ALL
Yes
Sponsors
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Aalborg University
OTHER
Responsible Party
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Giulia Erica Aliotta
PhD fellow
Locations
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Aalborg University
Aalborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Giulia Erica Aliotta
Role: primary
Other Identifiers
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N-20190062
Identifier Type: -
Identifier Source: org_study_id